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KP -1461trials are still going on from my infoi am getting emails one just yesterdaydo a search onclinicaltrials.gov or .orgforKP -1461it is still going on according to the guy that works for themupdate a few hours later..... i just met with one of the hiv researchers at a top west coast univ hiv research center, he said they are definately recruiting patients for KP -1461, he said he is very hopeful and enthusiastic about the trial, --- in my opinion... and this is me, talking... anyone who has resistance should run to the nearest univ research center and get on the trial, anyone who is in failing or having problems and facing some of the grim aspects of resistance and viral mutation, run , get on the website and get on this trial, i am not saying it is perfect, but i am saying it is or could be the best hope for anyone who is very very resistant and facing very dangerous waters, get on this trial, it is in every major us city.according to this dr. today

i posted why in another postbasically it is very zen very eastern medicine, very much turning the greatest strength of the virus, fast mutations, into its biggest weakness and using the mutations to distroyl the virus if you have failing haart and not many options -- i urge you to get on this trialif you have money and can fly to a city where there is a trial and you failing haart and not many med options

I thought something was fishy because there was a kp-1461 video on youtube that said kp-1461 possible hiv cure and people would comment on it and thing like that, and then I go to look at the video the other day and it say's this video has been removed by user. I was thinking why someone would remove this video and then today I hear about the trials being stopped, and now I am very sad. I hope your right Bimazek but why would project inform make this up,,,,,............. http://www.projectinform.org/news/2008/061208.shtml

Well this is terribly disappointing news. Bimazek, are there other trials occuring beyond the one that was cancelled according to Project Inform? The article datdude links to seems to be pretty final in its analysis that KP-1461 simply does not work. It didn't reduce viral load in human participants.

Again, I hope the article Project Inform created is leaving something substantial out, but I'd like to hear that from someone who's actually doing the research or closely associated with it. In the meantime, it seems that we have to cross this drug off the list of hopeful new therapies.

my boyfriend just recovered from deadly rashes (we suspect is Stevens-Johnson Sydrome) last weekend. I would say that it is one of the worst nightmare we had went through. Went to clinic (not his usual doctor) and seems to conclude he is better now. No more bleeding lips and swollen ulcers

We are praying everyday for the miracle kp-1461 this coming december. . .

Development of Koronis Pharmaceuticals’ KP-1461, an experimental antiretroviral (ARV), has been suspended after an analysis of existing data failed to show anti-HIV activity, according to a report by Project Inform. These results came as a surprise to Koronis and stand in contrast to the drug’s earlier lab studies that showed promise.

Though KP-1461 is technically a nucleoside reverse transcriptase inhibitor (NRTI), its mechanism of action is quite different from other drugs in this class of ARVs. Whereas current NRTIs are incorporated into developing DNA to stop the chains of genetic material from becoming fully formed and infectious, the integration of KP-1461 into developing chains of viral DNA causes the virus to produce defective, harmless versions of itself.

The U.S. Food and Drug Administration (FDA) had asked Koronis to do some additional lab studies to determine if HIV becomes resistant to KP-1461. During these lab studies, Koronis found that the drug had no measurable effect on HIV, a stark contrast to earlier studies that supported the drug’s clinical development. With the new results in hand, Koronis then analyzed blood samples from people enrolled in its ongoing clinical trial and, to their surprise, again found no anti-HIV activity.

Stephen Becker, MD, the lead investigator for Koronis, told Project Inform that the company is, “committed to understanding these discordant results and will attempt to validate the original 2002 research,” on KP-1461. Becker estimated that it will take at least two months to fully investigate this setback, and determine what comes next.

It is very disappointing, isn't it However, look at the bright sight, at least they found that in phase II better than on phase III. And if the therory is still work, they may just go back and check some other chemical that can function in the same way.

My question is, will they go back to KP-1212 (the primary form of KP-1461) or KP-1212 has same problematic issue and shall be reviewed again as well?

Maybe K company shall use KP-1212 to do the clinical trial instead of KP-1461

It is very disappointing, isn't it However, look at the bright sight, at least they found that in phase II better than on phase III. And if the therory is still work, they may just go back and check some other chemical that can function in the same way.

My question is, will they go back to KP-1212 (the primary form of KP-1461) or KP-1212 has same problematic issue and shall be reviewed again as well?

Maybe K company shall use KP-1212 to do the clinical trial instead of KP-1461

KP 1212 It is the active (supposedly active, not anymore) form of KP 1461, it is the same drug. Now, most experimental drugs will not make it to the market, everybody knows that. But the way they found that KP 1461 had no anti-viral activity was very strange. FDA asks Koronis to do lab tests to verify if HIV could grow resistant to KP 1461, then during these tests it is found that the drug is completely inactive against HIV, and only then Koronis checks how the patients in the clinical trials are faring, and confirms that they are getting no benefit at all from the drug. Also, Koronis should be the first to report this failure, and up to this date there is nothing in its website.

These small biotech companies....when they are really onto something important, a big pharma corp will rush to buy them. No big pharma company showed interest for Koronis, so that was a bad omen.

But the way they found that KP 1461 had no anti-viral activity was very strange

I think Koronis is full of shit. How could they get to Phase II without first replicating their results in a lab? They make it sound like they have never tried to replicate any findings in the lab prior to Phase II human trials - and that sounds like bullshit to me.

I'm looking forward to their more detailed conclusions.

Seems like they worked harder on their pretty flash animations than on testing their own drugs.

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October 2007 - Chose love/stupidity over protection23 April - Diagnosed30 April - CD4: 364/22.1% VL: 2,19811 July - Started Viramune/Truvada13 August - Undetectable

and only then Koronis checks how the patients in the clinical trials are faring, and confirms that they are getting no benefit at all from the drug.

Yeah, I also wondered about these issues. It was my understanding that clinical trial participants are typically monitored extremely closely for drug performance and for side effects. It would seem bizarre for Koronis to casually neglect monitoring the very purpose of the drug (not to mention the patients' safety and well-being!) until this FDA request just happened to emerge.

I think Koronis is full of shit. How could they get to Phase II without first replicating their results in a lab?

Don't be too judgemental, dear. Although it may be something wrong, it does not mean we can not find it out. KP-1461 is the pro-drug (correct me if I am wrong) of KP-1212, it means that, when discomposed by our liver, KP-1461 change into KP-1212. The news does not say, KP-1212 does not work, it says, KP-1461 does not work. It may be, in some situation, that this pro-drug form is not the correct form. Because the liver digestion process is very complicate, it may not changed to the form that is as active as KP-1212. This is the reason I ask this questions. It is possible that KP-1212 may still work? Back to Darwin's comment, I would say, according to standard process, the researcher must went thru in vitro--> in vivo of mice--> rabbit --> simian --> human. There must be some evidence show that it works before simian ones. All they need to do is to re-do rabbit and simian to check if it still works on them, then find what is wrong in human process. By saying this, I think it will be back, just give them some times........

Before everone makes assumptions, (and most here are not researchers or doctors), wait and see what the results are.. There are alot of approved (and very effective) HIV drugs that had issues in beginning phases but those issues were resolved later on.

An open label Phase 2a trial of KP-1461 was designed to evaluate the safety, efficacy and tolerability of KP-1461 as a monotherapy in treatment-experienced HIV-infected patients.

The study enrolled 27 of the 32 patients targeted for the trial. Koronis has suspended this trial to investigate a discrepancy in preclinical in vitro data and to examine Phase 2a clinical results. The trial suspension was not requested or required by the FDA and was not related to any safety concerns or adverse events during the trial. Clinical results have demonstated only occasional mild to moderate drug-related adverse events.

This news is hot off the press and I do not have any additional details other than what was reported in the Project Inform story.

Certainly Koronis will be evaluating why the two sets of results were so different. Dr. Becker hopes to have this ironed out by the time of the World AIDS Conference in Mexico City in August. Stay tuned. We'll keep you posted as the story unfolds. However, this setback is only one of many that we've had over the past quarter century as we've tried to develop effective medications and vaccines to combat HIV. It's another demonstration why we advise folks not to get overly enthusiastic about new drugs or novel therapies early in the course of their development. We've all been burned before!

I dont think you can get to encouraged about any new novel therapy until you have the pill in hand and you wash it down with a cold glass of water and it works for you. Until then just live each day to it fullest.

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Atheist don't believe in GOD, but GOD believes in them and loves them. Never let the failure of man conflict with your love of GOD.

I have not read all the in vitro data and I heard from a University researcher about 7 weeks ago that this drug hit a snag but i was too hopeful and didnt want to post the bad news because it came from one individual who runs trials at a university in a 5 second converstion, now that person is running a city health dept.. hopefully they will be able to change the molecule to get around the problems

it was like azt and the new nukes and non-nukes, a small change to the shape of the drug makes a huge difference and so i am still hopeful, the top research doc at one HIV research univ on west coast told me 7 days ago that he is still hopeful about this methodology - and he has dozens of MD people under him but i do know how much he knows -- of all the details

but i know now why long timers do not like to get thier hopes up with researchit hurts me when there is a glitch

the issue, and this is a guess, is that the shape of the molecule needs to be slightly different in humans than in animals because the shape of the target is different. i know it sounds funny but all these meds all the hiv meds and all drugs period work by the shape and electromagnetic attraction and repulsion of the molecules and if the shape or the key is slightly different it will not fit in

so an animals SIV shape is slightly different

hugs everyone

dont completely cross it off the list yetmaybe instead of being a possibility in 7 years it may be a possibility in 9 yearsi dont think it is ever more than a possibility until proven in humansso there is still hope in my book

Simply look at the histogram above and imagine the red bars (roughly) as tall as the blue ones - those are the in vitro data obtained after FDA required Koronis to repeat the serial passage experiments!So, KP-1212/1461 has NO anti-HIV activity even under the most favourable conditions (i.e. in vitro), and humans, animals, shapes and SIV are beside the point.

i thought that it was not suppose to be an anti-hiv medbut a mutation increaser so it would not stop hiv but increase the mutation rate so that the babies were unfitkind of like --so isnt it normal that it does not stop and kill hiv, it is suppose to allow hiv to grow but put a mutation that over the generations causes something like collapse of the population

BTW i posted on bimazek news -some great new stuff on why drugs fail -- from animals to humansthey just discovered alot of this in last 2-3 years

Ok, you thought; Koronis DID!So, may you please explain me how 15 serial passages in vitro IRREVERSIBLY ESTINGUISHED HIV in 2005 (see Koronis' histogram above again) and the SAME passages, when FDA required Koronis to repeat them, a few weeks ago, had NO EFFECT on the virus?

I dont think we will see a "cure" in our generation, but I think the treatment will continue to get better with less side effects and probably easier to take. Hopefully in terms of a shot that is taken like once a week or so. But as my doctors always tells me that treatment for HIV if great right now. But hopefully it continues to get better.

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Atheist don't believe in GOD, but GOD believes in them and loves them. Never let the failure of man conflict with your love of GOD.

I thought something was fishy because there was a kp-1461 video on youtube that said kp-1461 possible hiv cure and people would comment on it and thing like that, and then I go to look at the video the other day and it say's this video has been removed by user. I was thinking why someone would remove this video and then today I hear about the trials being stopped, and now I am very sad. I hope your right Bimazek but why would project inform make this up,,,,,............. http://www.projectinform.org/news/2008/061208.shtml

Yeah. I think it has to be one of three things: either Koronis fudged their results (not bloody likely; nothing to gain), they really screwed up the lab tests due to ignorance/negligence (again unlikely; these are the best research DOCTORS in their fields), or the FDA bigwigs are recieving financial kickbacks from big pharmaceutical companies because they know that this would take them out of the hiv picture (HUGE profit to be lost there if that happens). I think the third one makes the most sense because why does the FDA suddenly just now force Koronis to redo their in vitro tests, nearly three years AFTER they were first completed, and after the FDA reviewed, approved, and greenlighted kp-1461 for clinical trials. If the first lab tests were bogus, it would have been noticed by the half dozen or so people who had to review it (people who make six figures to do this, I might add). Also, Koronis officially stated that the phase 1 trials, while intended to evaluate tolerability and toxicity, also revealed encouraging effects on HIV levels in the subjects' blood. People who devote their lives to this kind of work get paid way too much to fuck up this royally (and this mistake is WAY too obvious), and aside from that they don't do it for the money (99.9% of all doctors I've ever met do their job out of passion to help people and don't really give a shit about money). I really don't mean to sound all conspiracy theory on you guys, but something really stinks here. I should also add that I'm not ranting out of denial; I'm HIV negative (I have a passion for this due to one of my childhood friends and his whole immediate family succumbing to aids back in the 80s). Anyway, thats my take on this issue so far, and will remain so until I am proven wrong (yeah right; as if Koronis, or any other sane company, would ever divulge whats really going on, especially if my theory is right). I wish you all the very best of luck and health in your struggle with this pandemic. Meanwhile, I'll continue to do my part by volunteering in my hometown when I can.

screw you, rapidrod. Its just my opinion with the limited info that I have. Whats your take on the situation, and what do you base that viewpoint on? If my post contains a logical fallacy, or is inaccurate in some way, please point it out, but save the smartass namecalling and dogging for someone who gives a shit what some uneducated inconsequential bum like you thinks.

screw you, rapidrod. Its just my opinion with the limited info that I have. Whats your take on the situation, and what do you base that viewpoint on? If my post contains a logical fallacy, or is inaccurate in some way, please point it out, but save the smartass namecalling and dogging for someone who gives a shit what some uneducated inconsequential bum like you thinks.

Good lord.

RapidRod is a respected member of these forums and, for the record, a highly trained clinician. You, on the other hand, are not.

You will not, I repeat NOT talk to any of our members in that manner, especially someone as well respected as RapidRod.

The only one doing any smartass namecalling is you....I'm giving you a warning, get rid of the attitude.

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screw you, rapidrod. Its just my opinion with the limited info that I have. Whats your take on the situation, and what do you base that viewpoint on? If my post contains a logical fallacy, or is inaccurate in some way, please point it out, but save the smartass namecalling and dogging for someone who gives a shit what some uneducated inconsequential bum like you thinks.

Excuse me? You dare to tell me how I will and won't speak to others? Where to begin? One, 1st amendment rights guarantee me free speech, meaning that if someone (ex. rapidrod) wnats to tell me to take my opinion elsewhere (this thread is pretty much 100% opinion) he can, and I can in turn tell him to fuck off. As long as I make no threat of violence and use no racial or ethnic slurs (although they are still perfectly legal, albeit tasteless) I'm in the clear. And what exactly is it you're going to do if I don't heed your warning? Boot me off the forums? Don't make me laugh; I simply signed up so I could comment on this one issue because I've been following it since the first clinical trials started. And what about this rapidrod? Upon looking at all of his most recent posts, he never has anything nice or constructive to add; only criticisms. Fair enough; his constituional right. I don't know how old you are, but I would have thought you'd have learned by now that if you don't have something nice to say, you don't have to keep it to yourself but you'd better expect to have the favor returned. One more thing: I wouldn't have had a problem with rapidrod pointing out exactly what he disagreed with, along with a sound rebuttal argument, but I do have a problem with "Take your conspiracy theories elsewhere" because it doesn't logically debunk my opinion; it simply tries to rob it of any merit with no explanation. If you're gonna criticize or disagree, you've gotta bring a suggestion (or at least an explanation of why you disagree) to the table.That being said, if any of you have any other ideas or new info on the situation regarding the latest in vitro results, I'd really like to hear it because Koronis has clammed up on the issue. To me, it just doesn't make sense for a company to fudge lab results to push a new drug knowing full well it doesn't work; its a waste of time because it won't pass clinical trials. Also, if the FDA had a problem with the lab results of the original in vitro tests, why in the hell would they greenlight the drug for clinical trials in the first place? It just seems funny that suddenly, years into the ordeal, they (FDA) decide they are not happy with the lab tests and all of a sudden the new lab results are completely contradictory to the original ones. It also stands to reason that big pharmaceutical companies stand to lose a hell of a lot of residual income if a short regimen totally eradicates HIV and HAART regimens (lifelong and expensive) are rendered obsolete and useless, so of course they would do everything in their power (legally and otherwise) to forestall or stop this altogether. Normally, I assume the best of people, but I happen to know several people who work for or have worked for pharmaceutical companies and many of them have quit due to extreme disgust with corruption and lack of ethics in the industry. I may very well be wrong here; I stated from the beginning that this was merely an opinion. In fact I hope I am wrong because corruption and greed to that extent is frightening. That's all I have to say on the topic.

Excuse me? You dare to tell me how I will and won't speak to others? Where to begin? One, 1st amendment rights guarantee me free speech, meaning that if someone (ex. rapidrod) wnats to tell me to take my opinion elsewhere (this thread is pretty much 100% opinion) he can, and I can in turn tell him to fuck off. As long as I make no threat of violence and use no racial or ethnic slurs (although they are still perfectly legal, albeit tasteless) I'm in the clear.

Actually you're quite incorrect. As a private message board, you have no "rights" guaranteed under the US Constitution. A moderator (anniebc aka Jan) has informed you that you've stepped over the line, which is entirely within the scope of her abilities on this forum.

"...health will finally be seen not as a blessing to be wished for, but as a human right to be fought for." Kofi Annan

Nymphomaniac: a woman as obsessed with sex as an average man. Mignon McLaughlin

HIV is certainly character-building. It's made me see all of the shallow things we cling to, like ego and vanity. Of course, I'd rather have a few more T-cells and a little less character. Randy Shilts

You're absolutely entitled to have and express your opinions BUT you cannot attack other members. That kind of flaming can earn you a time out and if extreme enough or repeatedly done will get you banned from the site.

Take a breath is what I suggest and don't go any further with these angry exchanges. If you have knowledge to share, that's great. Appropriate, polite behavior is expected here at all times.

It just seems funny that suddenly, years into the ordeal, they (FDA) decide they are not happy with the lab tests

I didn't manage to find any official FDA document, BUT Paul Dalton of "Project Inform", who was in contact with Koronis and was the first to publish the bad news [ http://www.projectinform.org/news/2008/061208.shtml ], wrote that the new KP-1461 in vitro tests were required by FDA to ascertain possible resistances: "Earlier tests failed to force resistance to KP-1461, so the FDA required Koronis to repeat them until resistance emerged."

My GUESS is that FDA request could have been linked to "compassionate use". I remember that, after terminating his phase II, a participant was given KP-1461 for compassionate use, with FDA approval. So, I SUPPOSE that, as the other participants terminate the trial achieving no eradication (the goal of KP-1461), this practice could extend. In this case, a more than rigorous resistance-risk test (we are referring to a MONOtherapy!) was imperative.

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and all of a sudden the new lab results are completely contradictory to the original ones

That's undeniable [ http://www.projectinform.org/news/2008/061208.shtml ]:"The lab tests that led to this decision [stopping the ongoing study of KP-1461] were required by the FDA and were essentially repeats of earlier work done by the company. The tests, called serial passage experiments, exposed HIV to different concentrations of the drug to try and force HIV to grow resistant to it."[...]"Surprisingly, they [Koronis' Sirs] found that KP-1461 didn’t show measurable anti-HIV activity, which conflicts with what was seen in earlier lab study."

That still doesn't explain how Koronis achieved repeated eradication in lab tests during the original series of experiments. Have any of you tried contacting Koronis directly? Whenever I do, I never get a response.